Senior Manager Regulatory Affairs

Medella Life; Frankfurt; Vor Ort; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A pharmaceutical company is seeking a Senior Regulatory Manager to lead regulatory affairs activities for dermatological products. This role involves developing and implementing regulatory strategies, ensuring compliance with EU regulations, and acting as the primary liaison with health authorities and regulatory agencies. Ideal candidates should have significant experience in regulatory affairs, especially related to dermatology products, along with a degree in life sciences or pharmacy. An analytical mindset and strong communication skills are essential.

Qualifikationen

• Significant experience in regulatory affairs within the pharmaceutical industry.
• Proven experience with dermatology products (Rx and/or OTC).
• Strong knowledge of EU pharmaceutical regulations.

Aufgaben

• Develop regulatory strategies for dermatology products across all lifecycle stages.
• Act as primary contact with health authorities and regulatory agencies.
• Monitor regulatory changes and assess impact on products.

Kenntnisse

Regulatory affairs experience

Dermatology knowledge

Excellent communication

Ausbildung

Degree in life sciences, pharmacy, or related field

Jobbeschreibung

Job Title: Senior Regulatory Manager (Pharmaceuticals – Dermatology)

Job Summary

The Senior Regulatory Manager is responsible for leading regulatory affairs activities for pharmaceutical products, with a particular focus on dermatology. This role ensures regulatory compliance across the full product lifecycle and provides strategic regulatory guidance to support product development, registration, and lifecycle management in line with EU and national regulatory requirements.

Key Responsibilities

• Develop and implement regulatory strategies for dermatology products across development, registration, and post-approval lifecycle stages.
• Prepare, review, and maintain regulatory submissions and dossiers (e.g. MAA, variations, renewals) in compliance with applicable regulations.
• Act as the primary point of contact with health authorities and regulatory agencies, supporting meetings, responses to questions, and ongoing communications.
• Monitor and assess regulatory changes and evaluate their impact on existing and pipeline dermatology products.
• Provide regulatory guidance to cross-functional teams including R&D, clinical, quality, pharmacovigilance, and commercial functions.
• Support product labelling, artwork, and promotional material review to ensure regulatory compliance.
• Contribute to risk management, post-marketing commitments, and regulatory compliance activities.
• Support audits, inspections, and internal reviews related to regulatory affairs.
• Maintain accurate regulatory documentation and tracking systems.

Qualifications & Experience

• Degree in life sciences, pharmacy, or a related scientific discipline.
• Significant experience in regulatory affairs within the pharmaceutical industry.
• Proven experience with dermatology products (Rx and / or OTC).
• Strong knowledge of EU pharmaceutical regulations and regulatory procedures.
• Experience working with health authorities and regulatory agencies.
• Excellent written and verbal communication skills.

Key Competencies

• Strategic and analytical thinking
• Strong project management and organizational skills
• Ability to work cross-functionally and influence stakeholders
• High attention to detail and regulatory compliance mindset